A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1

Bristol-Myers Squibb199 enrolled

Overview

To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.

US National Institutes of Health Division of AIDs (DAIDS)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

199

Conditions

Hepatitis C Virus

Interventions

DCV/ASV/BMS-791325DRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subject chronically infected with HCV genotype 1 (GT-1) * Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A) * HCV RNA ≥ 10,000 IU/mL at screening * Treatment-naïve subject with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.) * Interferon (IFN) experienced subject who have received previous treatment with IFNα, with or without RBV Exclusion Criteria: * Liver or any other transplant (including hematopoietic stem cell transplants) other than cornea and hair; * Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening; * Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed); * Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

Locations (20)

Local Institution

Kazan', Russia

Local Institution

Moscow, Russia

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort

Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.

Time frame: Post treatment Week 12

Secondary Outcomes

Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort

Percentage of treated participants with SVR12 in the IFNα experienced cohort, defined as HCV RNA \< LLOQ target detected or target not detected (LLOQ TD/TND).

Time frame: Post treatment Week 12

Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND

Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) \< lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, EOT, and follow-up Weeks 4 (SVR4), 8 (SVR8), and 24 (SVR24).

Time frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment)

Percentage of Participants Who Achieved HCV RNA < LLOQ TND

Percentage of treated participants with HCV RNA \< LLOQ, TND (target not detected) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, at both Weeks 4 and 12, EOT, and follow-up Weeks 4, 8, 12 and 24.

Time frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment)

Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment

SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.

Data from ClinicalTrials.gov

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